|Publication number||US7867267 B2|
|Application number||US 10/616,267|
|Publication date||Jan 11, 2011|
|Filing date||Jul 9, 2003|
|Priority date||May 20, 1999|
|Also published as||CA2371780A1, CA2371780C, DE60037802D1, DE60037802T2, EP1180003A1, EP1180003B1, US6607551, US20040106977, WO2000071058A1|
|Publication number||10616267, 616267, US 7867267 B2, US 7867267B2, US-B2-7867267, US7867267 B2, US7867267B2|
|Inventors||Jason R. Sullivan, John Keller, Matthew S. Ketterer, Kristian J. DiMatteo, Michael J. Bettuchi, Ellen Golds|
|Original Assignee||Boston Scientific Scimed, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (35), Non-Patent Citations (3), Referenced by (18), Classifications (9), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. patent application Ser. No. 09/574,418, filed on May 19, 2000 now U.S. Pat. No. 6,607,551.
This application claims priority based upon U.S. Provisional Application Ser. No. 60/134,985, filed May 20, 1999, and U.S. Provisional Application Ser. No. 60/157,335, filed Oct. 1, 1999.
This invention relates generally to endoluminal grafts or “stents” and, more specifically, to stent delivery systems or “introducers”.
A stent is an elongated device used to support an intraluminal wall. In the case of a stenosis, a stent provides an unobstructed conduit for blood in the area of the stenosis. Such a stent may also have a prosthetic graft layer of fabric or covering lining the inside and/or outside thereof. Such a covered stent is commonly referred to in the art as an intraluminal prosthesis, an endoluminal or endovascular graft (EVG), or a stent-graft. As used herein, however, the term “stent” is a shorthand reference referring to a covered or uncovered such stent.
A covered stent may be used, for example, to treat a vascular aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of rupture. Typically, a stent is implanted in a blood vessel at the site of a stenosis or aneurysm endoluminally, i.e. by so-called “minimally invasive techniques” in which the stent, restrained in a radially compressed configuration by a sheath or catheter, is delivered by a stent deployment system or “introducer” to the site where it is required. The introducer may enter the body through the patient's skin, or by a “cut down” technique in which the entry blood vessel is exposed by minor surgical means. When the introducer has been threaded into the body lumen to the stent deployment location, the introducer is manipulated to cause the stent to be ejected from the surrounding sheath or catheter in which it is restrained (or alternatively the surrounding sheath or catheter is retracted from the stent), whereupon the stent expands to a predetermined diameter at the deployment location, and the introducer is withdrawn. Stent expansion may be effected by spring elasticity, balloon expansion, or by the self-expansion of a thermally or stress-induced return of a memory material to a preconditioned expanded configuration.
Referring now to a typical prior art stent introducer as seen in
Delivery system 10 also may comprise a catheter tip 20 at its distal end attached to an internal sheath 23 that runs through the delivery system through inner lumen 22 in stabilizer 16, as shown in
To deploy stent 14, delivery system 10 is threaded through the body lumen to a desired location for stent deployment. Outer sheath 12 is then retracted, and stabilizer 16 acts as a stabilizer to keep stent 14 from retracting with the sheath. As outer sheath 12 retracts, stent 14 is exposed and expands into place in the body lumen to be repaired.
Some stents have relatively low column strength either along their whole length or in discrete sections thereof. Their low column strength may be an inherent result of a flexible stent architecture. Such low-column-strength stents or stent sections are easily deformed in a longitudinal direction, and thus longitudinal force is not transmitted along the length of the stent. This inability to transmit longitudinal force may result in such stents collapsing in an accordion fashion as the sheath is retracted or as the stent is ejected by movement of the stabilizer, when the stent is deployed using a standard stabilizer positioned at the proximal end of the stent. This collapsing is caused primarily by frictional forces, such as frictional forces between the sheath and the stent (in the case where the stent is deployed by retraction of the sheath) or between the stent and the body lumen (in the case where the stent is deployed by ejection). Thus, a low column strength segment is one which tends to collapse due to frictional forces upon deployment of the stent by a conventional stabilizer positioned at the proximal end of the stent. This collapsing may cause damage to the stent or incorrect deployment. Thus, it is desirable to employ a stent-stabilizer combination that avoids such collapse.
U.S. Pat. No. 5,702,418 to Ravenscroft, of common assignment with the present invention, discloses an introducer comprising a stabilizer having an inner core that underlies a compressed stent within a sheath. The core has one or two proximal rings attached to and extending radially from the surface of the inner core for engaging the compressed stent at the proximal end thereof. Ravenscroft further describes but does not illustrate stabilizer embodiments having additional rings, rings including slots for receiving portions of the stent overlying the rings, and rings formed or defined by a plurality of protuberances or fingers extending from the core to engage and interlock the stent minimum inner diameter at the proximal end thereof. The purpose of these rings, according to Ravenscroft, is to allow selective retraction and deployment of the stent.
Thus, it is known to have rings or protuberances that engage the inner diameter of the stent, but only with respect to one or more rings that engage the proximal end of the stent to enable selective retraction and deployment of the stent. There remains a need, therefore, for a means to facilitate deployment of endoluminal stents with relatively low column strength.
In accordance with this invention, there is provided a stent delivery system for receiving, endoluminally transporting, and endoluminally deploying an elongated stent for holding open a body lumen, which system facilitates the use of stents with low column strength. The stent delivery system comprises a stent, an overlying sheath, and a stabilizer. The stent has an inner periphery that defines an interior space extending lengthwise along at least a part of the stent, at least one longitudinal segment of which may comprise relatively low column strength (or reduced column strength as compared to other parts of the stent), in that such segment is easily collapsed longitudinally. Such a low column strength segment may comprise all or nearly all the length of the stent. The stent is adapted to be radially compressed and loaded within the delivery system for introduction into the body lumen and expanded for deployment within the body lumen. The sheath overlies the compressed stent during introduction of the stent within the body lumen from a proximal access location to a distal deployment location. The stabilizer is disposed within the stent interior space and has at least one surface element adapted to engage the stent inner periphery in a region containing the low-column-strength segment.
The stent may comprise a plurality of peripheral members disposed in succession along the length of the stent (i.e. longitudinally), in which case the stabilizer comprises at least one surface element adapted to engage individual peripheral elements in a manner capable of imparting a longitudinal force thereto. The stabilizer may comprise a plurality of protuberances positioned peripherally about the stabilizer such that the stabilizer engages the peripheral elements in a plurality of peripheral locations. The engagement between the protuberance and the peripheral element may be a frictional, engagement, or a direct mechanical engagement, for example where the protuberance penetrates an area of open space between peripheral elements of the stent.
The stabilizer typically comprises a surface element comprising one or more frictional surface areas, protuberances, or protrusions axially spaced along the stabilizer underlying the stent from a distal end to a proximal end of the low-column-strength segment, which may comprise the entire stent. The stabilizer may further comprise an inner core wherein the surface element is a sleeve or coating about the inner core. The surface element may further comprise radial protuberances in the form of rings about the inner core. The rings may be of various' cross-sections, such as rectangular or triangular, may have varying lengths in one section of the stabilizer relative to another, and may have spaces of various sizes between adjacent rings. The rings may be locking rings that further comprise protrusions that penetrate into the open space between peripheral stent elements. Instead of rings, the protuberances may instead be discrete barbs, bumps, or inflatable knobs that may be arranged in a ringed configuration about the stabilizer, or may be axially and peripherally spaced in a helical pattern.
Alternatively, the stabilizer may comprise an inner core and a heat-moldable compression sleeve surrounding the inner core, the heat-moldable compression sleeve having an outer surface comprising a plurality of surface elements defined by a thermal imprint of the stent inner periphery on the compression sleeve outer surface. The invention also comprises a corresponding method for loading a stent into the stent delivery system described above. The method comprises inserting the heat-moldable portion of the stabilizer within the stent interior space, compressing the stent so that the outer surface of the heat-moldable portion is in contact with the stent inner periphery, inserting the stent and underlying stabilizer within the outer sheath, and heating the stent delivery system to thermally imprint the heat-moldable portion outer surface with an uneven topography conforming to the stent inner periphery.
The stabilizer may instead comprise about its inner core an injection-molded sleeve having a similar structure to that described. In such an embodiment, the method for loading the stent comprises-radially compressing and loading the stent inside the sheath with the stabilizer inner core axially disposed within the stent interior space, and creating a sleeve over said inner core by injecting a thermoplastic material around the inner core to fill the interior space. The resulting injection-molded sleeve has an outer surface with an uneven topography conforming to the stent inner periphery.
The invention also comprises a method of delivering a stent using a stent delivery system as described herein, the method comprising urging the stent delivery system through the patient's body to a desired deployment location and displacing the sheath longitudinally relative to the stabilizer so that the protuberances engage the stent to displace the stent relative to the sheath.
The invention will next be illustrated with reference to the figures wherein similar numbers indicate the same elements in all figures. Such figures are intended to be illustrative rather than limiting and are included herewith to facilitate the explanation of the apparatus of the present invention.
As shown in
Although such device may also be referred to in the art as a “pusher”, the term “stabilizer” is used herein throughout because the preferred method of deploying the stent as used herein does not actually comprise “pushing” the stent out of the sheath, but rather “stabilizing” the stent (holding it in place and preventing it from moving) while the sheath is retracted. Use of the term “stabilizer” herein refers to such a device adapted for any method of use known in the art, however, including as a pusher, and is not intended as a limitation thereof.
Exemplary stent 34, as shown, comprises wire members bent into a series of zig-zags having apex sections and struts therebetween, axially-opposing apex sections being circumferentially offset from one another except for one set of axially-opposing apexes per helical rotation that are connected together, such as by spot-welding, so that the series of successive connected apex sections form a helical spine. Other stents may not have a defined spine. Some of the stents shown and described in U.S. Pat. No. 5,404,377—Cragg, U.S. Pat. No. 5,609,627—Goicoechia et al., U.S. Pat. No. 5,575,816—Rudnick, and U.S. Pat. No.4,655,771—Wallsten, which are incorporated herein by reference, may have low column strength depending on how they are made, among other factors. More specifically, in each case, the inherent stiffness and dimensions of the material of which the stent is constructed and the number and the nature of connections between stent elements will determine the column strength of the stent. For purposes of illustrating the present invention, stent 34 is assumed to be of low column strength throughout its length. In other embodiments, the stent used with the present invention may be of low column strength through only a part of its length with the nesting stabilizer of the present invention configured accordingly.
In exemplary stent 34, each peripheral element 19 as shown in
Stabilizer 30A or 30B is adapted to engage the stent inner periphery or low-column-strength portion thereof in a manner than enables transfer of longitudinal force to the stent without collapsing the low-column-strength portion. Preferably, stabilizer 30A or 30B comprises a surface element underlying stent 34 from proximal end 17 to distal end 15 of the stent along low-column-strength segment 18 and adapted for such engagement of the stent inner periphery. For example, the surface element may comprise a high friction surface, such as covering 138 as shown in
Stabilizer 30A as shown in
Generally, the frictional forces on stent 34 imparted by a thick, relatively low-hardness covering 138 may be depicted as shown in
Shear force V transmitted to stent 34 in the longitudinal direction is the relative force transmitted by stabilizer 30A to stent 34. This force may be derived either by pushing stabilizer 30A in the direction of force V or by holding the stabilizer steady while sheath 40 is retracted opposite the direction of force V. Shear force V must be less than the opposition force comprising the product of radial force F and the coefficient of static friction fS1 between covering 138 and stent 34. Otherwise, stent 34 will slip relative to covering 138. Shear force V is greater than the opposition force comprising the product of force F and the coefficient of static friction fS2 between sheath 40 and stent 34, causing sheath 40 to slip relative to stent 34. The relative motion of stent 34 is then opposed by the product of force F and the coefficient of dynamic friction fD2 between sheath 40 and stent 34. Thus, the coefficient of static friction fs1 between covering 138 and stent 34 is greater than the coefficients of friction fS2 and fD2 between stent 34 and sheath 40. For stabilizer 30A to move, the overall force X exerted on stabilizer 30A must also overcome the static opposition force fS3kF created by contact between covering 138 and sheath 40 and must counteract the dynamic opposition force fD3kF once the stabilizer is moving.
Because shear force V transmitted to stent 34 is limited by fS1F to prevent slip, increasing coefficient of friction fS1, or increasing force F serves to increase the maximum force V able to be transmitted. Force F can be increased by increasing the spring constant or the amount of resiliency of the covering material, or by increasing the outside diameter of covering 138 while keeping the inside diameter of sheath 40 constant, thus increasing the amount of deflection or indentation of covering 138 when stabilizer 30A is placed within sheath 40 inside stent 34. Increasing force F in this manner also increases the force transmitted from the stent 34 to sheath 40 and from covering 138 to sheath 40, however, thus increasing the opposing frictional forces to shear force V, and thereby requiring a larger overall force X to be exerted on stabilizer 30A for deployment. The overall force X exerted on stabilizer 30A required to initiate and sustain relative motion of stent 34 with respect to sheath 40 may be minimized by decreasing the coefficients of friction fS2, fD2, fS3, and/or fD3 and/or by reducing the surface area of contact between covering 138 and sheath 40, and/or by decreasing radial force F. It is desirable to maximize shear force V transmitted to stent 34 for a minimum overall force X exerted on stabilizer 30A.
One way of reducing the overall force X is to reduce the frictional opposition force between sheath 40 and covering 138 and the amount of radial force transmitted to sheath 40 from stent 34 by reducing the amount of surface area where covering 138 contacts sheath 40 and/or stent 34. Thus, in the embodiment shown in
Another way of reducing the overall force X is to eliminate all direct contact between covering 138 and sheath 40, such as is shown in the stabilizer embodiment depicted in
In another embodiment, the amount of friction imparted to sheath 40 may be minimized and the amount of force transmitted to stent 34 maximized by providing protuberances in the form of protrusions 60, such as are shown, for example, in
The embodiments having forces as illustrated in
Various exemplary stabilizer embodiments are shown in
Thus, a stent delivery system in accordance with the present invention may comprise any of exemplary stabilizers 30 A-30 J as illustrated in
The rings according to the present invention may have a rectangular cross-sectional geometry as shown in.
As shown in
The various rings may also have different lengths as well as different spacing patterns, as shown in
In addition to or instead of different spacing patterns, the rings in one section may comprise a different material or slightly different diameter than the rings in another section. For instance, referring to
The various combinations of ring spacing, lengths, and geometry are not limited to the examples presented herein, but rather may be tailored to the needs of the specific stent and deployment circumstances. Also, as shown in
As shown in
Instead of using locking rings 56, a low-profile introducer may instead comprise protuberances in the form of protrusions 60 peripherally spaced in a ring about core 32 to engage the stent in multiple peripheral locations, as illustrated by stabilizers 30 H and 30 I in
A stabilizer having inflatable knobs 60 C may be inflated by, for example, injecting saline solution into the stabilizer or by any inflation means known in the art. Inflatable knobs 60 C offer the capability of conforming to the shape of the stent when the stabilizer is inflated. Another capability of a stabilizer with inflatable knobs 60 C is that one stabilizer may be used for loading a stent into the stent delivery system and a different stabilizer used for deploying the stent. In suchecase, the inflatable stabilizer is merely deflated after loading the stent and then removed. Another inflatable stabilizer can then be inserted in its deflated configuration into the inner periphery of the stent and inflated when deployment is required. Thus, for example, if one stabilizer configuration is preferred for loading the stent and another configuration preferred for deploying the stent, specialized stabilizers may be developed for each specific purpose.
Rather than the protrusions forming or defining rings, the protrusions may extend radially from the inner core surface in a helical pattern, as shown in
Another structure enabling deployment of a low-column-strength stent is shown in
For the heat-imprinted compression sleeve, stent 34 is loaded into stent delivery system 136 by a method comprising the following steps. First, compressed stent 34 is placed overtop heat-moldable compression sleeve 66. Next, stent 34, compression sleeve 66, and inner core 32 are inserted inside an outer sheath 40. Then, stent delivery system 136 is heated, such as with a hot air gun, beyond the glass transition temperature of compression sleeve 66. This heating step thermally imprints the compression sleeve 66 outer surface 68 with an uneven topography conforming to the stent inner periphery 70. Inner core 32 and outer sheath 40 each preferably comprise a material, such as poly-ether-ether-ketone (PEEK) or polyimide (PI), having a heat deformation temperature greater than the heat deformation temperature of heat-moldable compression sleeve 66, so that only the compression sleeve deforms during the heating step. Compression sleeve 66 may be constructed of any common thermoplastic material, for example but not limited to, EVA, Pebax® resin, thermoplastically deformable nylons, and thermoplastic polyurethanes, such as Tecothane®.
Instead of compression sleeve 66 being a discrete sleeve that is subsequently heat-molded, sleeve 66 may instead be formed by injection molding. For example, stent 34 may be loaded inside sheath 40 with inner core 32 axially disposed therein, and one of the above-listed materials injected to fill the space between the inner core and the stent. In this way also, an imprinted sleeve 66 will be formed about core 32 having an outer surface 68 with an uneven topography conforming to the stent inner periphery 70.
Thus, according to the present invention, a stent is delivered and deployed by the following method steps. A stent delivery system, such as system 36A or 36B as shown in,
With any of the stabilizer embodiments described above, in addition to facilitating deployment of stents having low-column-strength segments, the nested stabilizer of the present invention may additionally facilitate recapture during deployment of a stent. “Recapture” refers to retracting a partially deployed stent so that it may be repositioned relative to the deployment location. To the extent that a nested stabilizer encompassed by the present invention engages the proximal end of the stent, until that proximal end has been deployed, the stabilizer configuration may enable retraction of the stent relative to the sheath in a direction opposite the deployment location. So, for instance, when it is discovered prior to complete deployment that the stent is not in the desired location or not deploying correctly, the stent may be recaptured within the sheath by retracting the stabilizer or otherwise moving the sheath relative to, the stent to envelop the stent again, at which time the deployment process may be re-initiated. Thus, the term “stabilizer” should not be read to mean that it is only capable of resisting movement of the stent in one direction. The stabilizer of the present invention can also be used to transmit a longitudinal force to the low-column strength segment in the distal or proximal direction whenever the stent needs to be moved relative to an outer sheath, including when the stent is being loaded in the sheath.
In addition to the heat-resistant qualities of PEEK and PI making these polymers especially well-suited as materials of construction for sheath 40 in the embodiment shown in
While the present invention has been described with respect to specific embodiments thereof, it is not limited thereto. Therefore, the claims that follow are intended to be construed to encompass not only the specific embodiments described but also all modifications and variants thereof which embody the essential teaching thereof.
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|U.S. Classification||623/1.11, 606/108|
|International Classification||A61F2/82, A61F2/84, A61F2/06|
|Cooperative Classification||A61F2002/9583, A61F2002/9665, A61F2/95|
|Jun 26, 2013||AS||Assignment|
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